Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia

• AMAG-423 (digoxin immune fab) (Biological), also known as DigiFab: AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
• Placebo (Other): Normal saline, 30 minute IV infusion, every 6 hours x 4 days

Primary outcomes

• Proportion of Infants Who Have Severe IVH, NEC, or Death by 36 Weeks Corrected Gestational Age [36 weeks corrected gestational age]: Proportion of infants who have severe IVH, NEC, or death by 36 weeks corrected gestational age

Secondary outcomes

• Change From Baseline in Serum Creatinine [From treatment initiation to 24 hours post first dose]: Maternal change from baseline in serum creatinine to 24 hours post first dose
• Incidence of Pulmonary Edema [From treatment initiation until completion of treatment phase (up to 4 days)]: Maternal incidence of pulmonary edema during the treatment period

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* Fetal gestational age 23 0/7 to 31 6/7 weeks
* Treated with expectant management
* Meets modified ACOG criteria for severe preeclampsia
* Willing and able to provide written, informed consent

Exclusion Criteria:

* Decision to deliver within 24 hours has been made
* Weight > 150 kg
* Eclampsia
* Significant antecedent obstetrical problems
* Clinically significant fetal anomaly or chromosomal abnormalities
* Chronic renal disease
* Active hepatic disease, antiphospholipid antibody syndrome, or lupus
* Unstable medical or psychiatric disorder
* Need for use of digitalis like products
* History of anaphylactic allergic reactions
* Prior use of antibodies/fab fragments from sheep
* Serum creatinine ≥ 2.0 mg/dL
* Platelet count < 50,000
* Pulmonary edema
* Estimated fetal weight < 5th percentile

Participant flow

Outcome results

• Proportion of Infants Who Have Severe IVH, NEC, or Death by 36 Weeks Corrected Gestational Age (Primary), Number, infants: AMAG-423 (Digoxin Immune Fab) 4; Placebo 3
• Change From Baseline in Serum Creatinine (Secondary), Mean, μmol/L: AMAG-423 (Digoxin Immune Fab) 1.0 +/- 8.51; Placebo -2.8 +/- 9.45
• Incidence of Pulmonary Edema (Secondary), Number, Events: AMAG-423 (Digoxin Immune Fab) 0; Placebo 2

Adverse events

Time frame: 36 weeks

Serious adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2018-11-08)